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Right now, more than 116,000 people are on the U.S. organ transplant waiting list. But what if they could just regrow their own livers, hearts, and kidneys, even 3-D print them? Anthony Atala, the director of the Wake Forest Institute for Regenerative Medicine, is working to make that a reality. Speaking today at Ciudad de las Ideas, an annual conference about big ideas held in Puebla, Mexico, and sponsored by Grupo Salinas, Atala asked, "If a salamander can do it, why can't we?"

So how long until regenerative medicine can make the agonizingly long transplant waiting list a thing of the past? Within the next decade, Atala predicts, "we will see partial replacements of [some] organs - not the entire replacement, but many times that's all we need." Of course, the very necessary regulatory process will have to be carried out before there is widespread use of regenerated organs. Atala notes that the average drug takes 15.5 years to be approved in the United States, and regenerative medicine is neither drug nor medical device, but a combination thereof, which makes approval even more complicated.

Worse, regulators can declare entire potential fields of medicine forbidden, as is the case for applications of longevity science. Aging is not a defined disease for the FDA, and all that is not explicitly permitted is forbidden in their regulatory rubric - so there is no path to legally commercialize a therapy for aging in the US, even when it becomes technically possible to do so. Thus there is little to no funding for such development.

The medicines that might have been and the progress that might have happened is all invisible, of course, so few people pay any attention to it - the broken window fallacy again, where the harm done and costs incurred are swept under the carpet, so people can suggest that we are all better off for it. How much further might medical science have advanced if the ruinous cost of clinical trial after trial after trial, under far more onerous requirements than existed even a few decades ago, were instead funneled into more research?

To explain the seeming gap between accelerating progress in the laboratory and lagging slowness in clinical medicine, one only has to point to the regulators. They are to blame, and the rest of us for not doing something about this squalid situation.

Comments

I agree that the regulatory process is cumbersome and time consuming. However, what do you envision taking the place of the FDA? Perhaps you discussed this issue in a blog post that I missed.

How about China? Or Thailand? The FDA is not going to change itself, nor is going away, either. It will remain in place, slowly calcifying and blocking progress. Instead of people wasting money and energy fighting companies and interest groups pushing in the opposite direction, efforts are best spent elsewhere in a better regulator environment.

It is a big world, and 95% of it is NOT in the U.S.A. It is true that horror stories will come out of less regulated venues--there WILL be corruption, quacks, fraud, and unethical experiments. But there will also be unencumbered research, speedy results, and miracle cures.

There is no advancement without risk. The American system is no longer able to weigh risk v. reward appropriately. A dying patient may take a gamble on an unproven treatment and get lucky, but for the American regulatory system, I'm afraid the prognosis is bleak.

Posted by: Paul at November 11, 2012 8:11 PM

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